Is There a Generic Jardiance Available?
No, no generic version of Jardiance (empagliflozin) is available in the US as of now. The brand remains under patent protection, with key patents blocking generic entry until at least 2028 for some formulations.[1]
When Do Jardiance Patents Expire?
Jardiance's main composition-of-matter patent (US 7,713,938) expires in 2025, but secondary patents extend protection. The longest-running patent (US 9,593,073 for specific crystalline forms) lasts until March 2033, though some are listed as expiring earlier in 2028-2031. Pediatric exclusivity adds six months to these dates.[1][2]
Are There Any Approved Generic Competitors?
No ANDAs (Abbreviated New Drug Applications) for empagliflozin generics have been FDA-approved. Boehringer Ingelheim and Eli Lilly, the makers, have faced Paragraph IV challenges from companies like Mylan and Sun Pharma, but all are pending or dismissed. No generics have cleared the litigation hurdles.[1][3]
What About Authorized Generics or Biosimilars?
Jardiance is a small-molecule drug, so it follows the generic (ANDA) pathway, not biosimilars. No authorized generic exists from the brand makers either.[1]
When Can We Expect Generics to Launch?
Earliest realistic launch is mid-2028 after key Orange Book patents expire, assuming no further extensions or successful challenges. Ongoing lawsuits could shift this; for example, a 2023 settlement with some challengers is confidential but doesn't allow immediate entry.[1][2]
Is Jardiance Available Generically Outside the US?
In Europe, generics launched in some countries post-2022 patent expiry there, but US rules differ due to separate patent listings. Importing non-FDA-approved versions is illegal and risky.[4]
Sources
[1]: DrugPatentWatch.com - Jardiance Patents
[2]: FDA Orange Book - Empagliflozin
[3]: FDA Paragraph IV Patent Challenge Database
[4]: EMA - Empagliflozin Authorizations